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Monoclonal Antibodies

BIIB132 for Spinocerebellar Ataxias

Phase 1
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 267
Awards & highlights

Study Summary

This trial is testing a new medication for safety and how well it works in people with spinocerebellar ataxia type 3.

Eligible Conditions
  • Spinocerebellar Ataxia Type 3

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 267
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 267 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Adverse Events (AEs)
Number of Participants with Serious Adverse Events (SAEs)
Secondary outcome measures
Area Under the Concentration Versus Time Curve, from Time of Dosing (Time = 0) to Infinity (AUCinf) of BIIB132
Area Under the Concentration Versus Time Curve, from Time of Dosing (Time = 0) to Time of the Last Measurable Effect (AUClast) of BIIB132
Area Under the Concentration-Time Curve (AUC) of BIIB132
+3 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 5: BIIB132 Dose 5 or Matching PlaceboExperimental Treatment2 Interventions
Participants will be randomized to receive BIIB132 Dose 5 or matching placebo, IT, either Q4W or every 12 weeks (Q12W), up to Day 85 or every 8 weeks (Q8W) up to Day 57.
Group II: Cohort 4: BIIB132 Dose 4 or Matching PlaceboExperimental Treatment2 Interventions
Participants will be randomized to receive BIIB132 Dose 4 or matching placebo, IT, Q4W, up to Day 85.
Group III: Cohort 3: BIIB132 Dose 3 or Matching PlaceboExperimental Treatment2 Interventions
Participants will be randomized to receive BIIB132 Dose 3 or matching placebo, IT, Q4W, up to Day 85.
Group IV: Cohort 2: BIIB132 Dose 2 or Matching PlaceboExperimental Treatment2 Interventions
Participants will be randomized to receive BIIB132 Dose 2 or matching placebo, IT, Q4W, up to Day 85.
Group V: Cohort 1: BIIB132 Dose 1 or Matching PlaceboExperimental Treatment2 Interventions
Participants will be randomized to receive BIIB132 Dose 1 or matching placebo, intrathecally (IT), every 4 weeks (Q4W), up to Day 85.

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor
639 Previous Clinical Trials
467,314 Total Patients Enrolled
2 Trials studying Spinocerebellar Ataxias
184 Patients Enrolled for Spinocerebellar Ataxias
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,064,396 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are currently participating in this clinical experiment?

"The clinical trial needs 48 eligible patients to begin. The sponsor, Biogen, will be running the study from locations including University of Pennsylvania in Philadelphia, and Research Site in San Francisco, California."

Answered by AI

Has BIIB132 been granted authorization from the FDA?

"The safety of BIIB132 is estimated to score a 1 on our scale, as this Phase 1 trial has yet to provide sufficient evidence for both efficacy and safety."

Answered by AI

Is the age requirement for this clinical trial greater than 30 years?

"The parameters for this research necessitate that participants are between 18 and 70 years old. There are, however, 33 trials targeting those older than 65 and an additional 18 clinical investigations available to minors."

Answered by AI

Who can participate in this medical research project?

"If a person has spinocerebellar ataxia type 3 and is between 18 to 70, they may qualify for this investigational trial. This study will be recruiting 48 participants in total."

Answered by AI

How widely dispersed are the sites conducting this clinical research across America?

"This trial is administered by 21 different sites, the most prominent of which are University of Pennsylvania in Philadelphia, Research Site in San Francisco, and UF Health Neuromedicine in New york. The remainder can be found at various other locations around the country."

Answered by AI

Are there presently opportunities for participants to enroll in this trial?

"Yes, the information hosted on clinicaltrials.gov confirms that this medical trial is currently looking for applicants. The initial posting was February 2nd 2022 and it has been edited as recently as November 8th 2022. There are 48 openings spread out across 21 locations in total."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
18 - 65
What site did they apply to?
Research Site
UF Health Neuromedicine
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Email
Most responsive sites:
  1. UF Health Neuromedicine: < 24 hours
Recent research and studies
clinicaltrials.govStudy
A Pharmacokinetics and Safety Study of BIIB132 in Adults With Spinocerebellar Ataxia 3
2022. "A Pharmacokinetics and Safety Study of BIIB132 in Adults With Spinocerebellar Ataxia 3". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05160558.
~3 spots leftby May 2025
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